MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT

K023048 · Beckman Coulter, Inc. · JXM · Nov 7, 2002 · Clinical Toxicology

Device Facts

• Record ID: K023048
• Device Name: MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
• Applicant: Beckman Coulter, Inc.
• Product Code: JXM · Clinical Toxicology
• Decision Date: Nov 7, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3170
• Device Class: Class 2

Intended Use

Benzodiazepine (BENZ) Reagent, in conjunction with SYNCHRON ® Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of benzodiazepines in human urine at a cutoff value of 200 nq/mL, on SYNCHRON Systems. The Benzodiazepine assay provides a rapid screening procedure for determining the presence of benzodiazepines in urine. This test provides only a preliminary analytical result; a positive result by this assay should be confirmed by another generally accepted non-immunological method, such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Story

Reagent kit for qualitative detection of benzodiazepines in human urine; used on SYNCHRON CX and LX clinical chemistry systems. Input: human urine sample; reagent-sample mixture. Principle: immunoassay-based screening. Output: preliminary qualitative result indicating presence or absence of benzodiazepines above 200 ng/mL cutoff. Used in clinical laboratory settings by trained personnel. Results assist clinicians in identifying potential drug use; positive results require confirmation via GC/MS or similar non-immunological methods. Modification involves updated antibody for improved drug cross-reactivity.

Clinical Evidence

Bench testing only. Performance data provided to support equivalency of the modified antibody reagent compared to the predicate device.

Technological Characteristics

In vitro diagnostic reagent kit; immunoassay-based; designed for use on automated SYNCHRON CX and LX clinical chemistry analyzers. Modification: updated antibody for drug cross-reactivity. Qualitative detection at 200 ng/mL cutoff.

Indications for Use

Indicated for qualitative screening of benzodiazepines in human urine at a 200 ng/mL cutoff. Intended for use as a preliminary analytical test requiring confirmation by non-immunological methods (e.g., GC/MS).

Regulatory Classification

Identification

A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A benzodiazepine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

• SYNCHRON Systems Benzodiazepine Reagent (K944076)

Submission Summary (Full Text)

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K023048

NOV 7 2002

# 510(k) SUMMARY

#### 1.0 Submitted By:

Annette Hellie Requlatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 Brea, CA 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted

September 12, 2002

#### 3.0 Device Name(s):

- 3.1 Proprietary Names SYNCHRON Systems Benzodiazepine Reagent
- 3.2 Classification Names Benzodiazepine test system. [862.3170]

#### 4.0 Legally Marketed Device

The SYNCHRON Systems Benzodiazepine Reagent claims substantial equivalence to the SYNCHRON Systems Benzodiazepine Reagent currently in commercial distribution. (FDA 510(k) Number K944076)

#### 5.0 Device Description

The SYNCHRON Systems Benzodiazepine (BENZ) reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4/4PRO, CX5/5CE/5Δ/5PRO, CX7/7RTS/7Δ/7PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems. The reagent kit contains one 250-test cartridge that is packaged separately from the associated calibrators.

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#### 6.0 Intended Use

Benzodiazepine (BENZ) Reagent, in conjunction with SYNCHRON ® Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of benzodiazepines in human urine at a cutoff value of 200 nq/mL, on SYNCHRON Systems.

The Benzodiazepine assay provides a rapid screening procedure for determining the presence of benzodiazepines in urine. This test provides only a preliminary analytical result; a positive result by this assay should be confirmed by another generally accepted non-immunological method, such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method.

Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

### 7.0 Comparison to the Predicate (Description of the Modification to the Legally Marketed Device)

The SYNCHRON Systems Benzodiazepine reagent antibody has been modified for drug cross-reactivity.

#### 8.0 Summary of Performance Data

Performance data from validation testing supports equivalency.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of three overlapping human figures.

NOV 7 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Annette Hellie Regulatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 P.O. Box 8000 Brea. CA 92822-8000

k023048

Re:

Trade/Device Name: Synchron® Systems Benzodiazepine Reagent Regulation Number: 21 CFR 862.3170 Regulation Name: Antimony test system Regulatory Class: Class II Product Code: JXM Dated: October 24, 2002 Received: October 24, 2002

Dear Ms. Hellie:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally; for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other veneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours.

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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03304 510(k) Number (if known):

SYNCHRON® Systems Benzodiazepine Reagent Device Name:

Indications for Use:

Benzodiazepine (BENZ) Reagent, in conjunction with SYNCHRON ® Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of benzodiazepines in human urine at a cutoff value of 200 ng/mL, on SYNCHRON Systems.

The Benzodiazepine assay provides a rapid screening procedure for determining the presence of benzodiazepines in urine. This test provides only a preliminary analytical result; a positive result by this assay should be confirmed by another generally accepted non-immunological method, such as thin laver chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method.

Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (per 21 CFR 801.109)

Over-the-Counter Use Optional Format 1-2-96

Alan Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number .

Beckman Coulter, Inc., Special 510(k) Device Modification SYNCHRON® Systems Benzodiazepine Reagent File: BENZ s510k.doc 9/02